Oral Dose Drug Product Development & Manufacturing
Product Description
WuXi STA
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US -
2015On CPHI since
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3Certificates
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5000+Employees
Company types
Categories
WuXi STA
-
US
-
2015On CPHI since
-
3Certificates
-
5000+Employees
Company types
More Products from WuXi STA (13)
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Product Highly Potent API (HPAPI), ADC Payload, and Payload-Linker Manufacturing
Our Jinshan and Changzhou sites are equipped with multiple R&D labs as well as a dedicated cGMP HP Kilo lab and plant for producing and manufacturing highly potent APIs (HPAPI's), antibody drug conjugates (ADC's), payloads, and payload-linkers. We currently offer drug product manufacturing at STA’... -
Product Analytical Development Services
Our comprehensive suite of analytical services help to supplement the development and manufacture of your product, ensuring high quality and consistency throughout the process.
Services include:
- Analytical method development and validation
- API and drug product release tes... -
Product in-vivo PK Studies
Our drug product pre-formulation and formulation development services can also includes in vivo PK studies, conducted with multiple animal species and a rapid turnaround time. This additional service further extends our full suite offering to our clients while eliminating the need for additional vendor sou... -
Product Injectable Formulation Development & Fill-Finish Services
WuXi STA offers a wide range of tailored services and solutions for clients developing injectable formulations. Form types include solution, emulsion, sterile powder (lyophilized) and liposome. Our offering includes formulation development, performance analysis and characterization testing, and fill/... -
Product Global Regulatory Affairs & CMC Submission Support
WuXi STA's dedicated Global Regulatory Affairs CMC teams offers comprehensive CMC documentation support for IND, CTA, MAA, and NDA applications in western countries and China. Our highly experienced team works with your NCE programs to prepare Module 2 and Module 3 of your regulatory dossier through foreca... -
Product Packaging & Labeling Solutions
At WuXi STA, we understand the need for flexibility at the early stages of clinical testing and how aspects such as effective dose, stability and compliance requirements can change your needs abruptly. Our packaging team will work with you to collect the relevant data and test various packaging options as ... -
Product F2CS - "Fast to Clinical Supply" Platform
Your innovative therapy is ready to reach a key milestone with the IND date quickly approaching. You need a reliable partner to formulate and manufacture your therapy to meet the IND filing requirements and the dose needs for phase I studies fast.
Every innovation is unique so your partner needs... -
Product F4CL - "Fast for Commercial Launch" Platform
When your CMC projects approach the final step to commercial approval, you need to consider how to be sure your drugs successfully reach your intended markets.
Regulatory agencies have different requirements and timing. Trust in the right partner so you don’t need to worry abou... -
Product IND Enabling Preformulation Package (IEPP)
WuXi STA's IND Enabling Pre-formulation Package (IEPP) is an integrated and end-to-end developability assessment service for new chemical entities (NCE's). Through this comprehensive service, you can efficiently identify challenges and tailored solutions earlier for higher project success rates and lower o... -
Product Small Molecule API Development & Manufacturing
WuXI's unrivaled API development platform provides our client with a robust platform to bring their drug to market. With a proven track record of success and trust in bringing life changing therapeutics to market, we are a go-to partner for clients looking for tailored and customized drug development and m... -
Product Bioavailability Enhancement & Advanced Delivery Technologies
Our bioavailability toolbox offers a customizable solution to your drug delivery challenges.
- Spray-Dried Dispersion (SDD)
- Hot Melt Extrusion (HME)
- Nano-suspensions & Lipid Nanoparticles
- Softgel & Liquid Filled Capsules
- Injectable Formulations\
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Product Peptide CRDMO Platform
WuXi TIDES's Peptide platform includes a complete offering of services to bring your protein therapeutic to market faster while supporting a wide variety of conjugates including PPMO, Peptide-Antibody, Peptide-Linkers.
Services include but are not limited to: - Comprehensive Discovery Service...
WuXi STA resources (2)
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News New drug product service delivers expedited CTM
Biotech and pharma innovators are facing considerable challenges to find CDMO partners with capacity and capability to quickly develop and deliver high-quality CTM with flexible options+
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